MAUDE Adverse Event Report: SYNTHES (USA) TI DISTRACTION LOCK; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.125

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported during a planned procedure on (b)(6) 2014 to remove and replace veptr rods due to patient's growth, one of the proximal extension rods was found to be broken, and the distraction lock was found to be disengaged.The surgeon removed 2 rods, 2 nuts and one cap.The distraction lock was re-engaged, and not removed.Rods were replaced by larger size rods to accommodate patient's growth.There was reportedly no harm to the patient.X-ray images taken on (b)(6) 2014 indicate the extension rod was not broken at that time.Patient's status following the procedure was reportedly stable.An internal review of the x-rays was performed by the spine medical director the review reported on (b)(4) 2014: an ap and a lateral radiograph of the thoracolumbar spine demonstrating veptr instrumentation in patient with thoracic curve (49 degrees according to provided measurement).The review was unable to suggest any root cause based on anatomic factors in these limited views (and no pre- and post-breakage image comparison).On lateral x-ray, there appears to be a discontinuity in the proximal portion of the rod, suggesting the described breakage.I cannot appreciate the disengaged distraction lock on the x-rays due to picture quality.Dates of x-rays in relation to event to be provided by sales consultant, if further information or images become available, the images will be reviewed and compared to the ones reviewed in this report.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.

• Brand Name: TI DISTRACTION LOCK
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3753968
• MDR Text Key: 17385057
• Report Number: 2520274-2014-10787
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1